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Health Highlights: April 12, 2021
Chinese COVID-19 Vaccines Not Very Effective: Official Chinese COVID-19 vaccines "don't have very high protection rates," the director of the China Centers...
Scammers Selling Fake COVID-19 Vaccination Cards
MONDAY, April 12, 2021 -- Fake COVID-19 vaccination cards are being sold online at sites such as eBay, Etsy, and Shopify, and bogus ads for the cards are...
Chinese COVID-19 Vaccines Not Very Effective: Official
MONDAY, April 12, 2021 -- Chinese COVID-19 vaccines "don't have very high protection rates," the director of the China Centers for Disease Control admitted...
FDA to Decide 'Quickly' on Pfizer Request to Approve COVID-19 Vaccine for Children 12 to 15
MONDAY, April 12, 2021 -- The Pfizer request to expand emergency use authorization of its COVID-19 vaccine to include children ages 12 to 15 years will be...
FDA OKs Marketing of First AI Device Used to Detect Lesions During Colonoscopy
MONDAY, April 12, 2021 -- The U.S. Food and Drug Administration cleared the way for marketing of the first device to use artificial intelligence based on...
Antibody Cocktail May Curb Infection in Unvaccinated Exposed to COVID-19
MONDAY, April 12, 2021 -- People living with someone who has COVID-19 appear to get powerful protection against infection when they are given the Regeneron...
Sluggish Coworker? Maybe They 'Pigged Out' Last Night
MONDAY, April 12, 2021 -- Midnight snacks might feel satisfying in the moment -- but they can also knock people off their game at work the next day, a new...
Could Widely Used Blood Pressure Meds Raise Skin Cancer Risk?
MONDAY, April 12, 2021 -- Most people are familiar with common sun-protection advice, from wearing and reapplying sunscreen to putting on a hat. But a new...
Making E-Cigs Cool: Singers, Models in Music Videos Get Teens Vaping
MONDAY, April 12, 2021 -- DJ Khaled, Halsey and other musicians are selling electronic cigarettes to young people through product placement in music videos...
AHA News: Instructed in CPR By 911 Dispatcher, Nebraska Couple Saves 13-Day-Old Son
MONDAY, April 12, 2021 (American Heart Association News) -- During a nightly TV newscast in January, anchor Bill Schammert's voice broke as he described why...
FDA Approves Trodelvy, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival
FOSTER CITY, Calif.--(BUSINESS WIRE)--Apr. 7, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has...
Pfizer Announces Extension of Review of New Drug Application of Abrocitinib for the Treatment of Moderate to Severe Atopic Dermatitis
NEW YORK--(BUSINESS WIRE) April 07, 2021 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has extended the priority...
FDA Approves Qelbree (viloxazine) for the Treatment of ADHD
ROCKVILLE, Md., April 02, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and...
FDA Approves Sarclisa (isatuximab-irfc) in Combination with Carfilzomib and Dexamethasone for Patients with Relapsed or Refractory Multiple Myeloma
PARIS, March 31, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved Sarclisa (isatuximab-irfc) in combination with carfilzomib and...
FDA Approves Roszet (rosuvastatin and ezetimibe) to Reduce LDL-C in Hyperlipidemia and Homozygous Familial Hypercholesterolemia
Morristown, N.J. March 31, 2021 -- Althera Pharmaceuticals, a company focused on heart health, today announced the FDA approval of Roszet (rosuvastatin and...
Jazz Pharmaceuticals Announces FDA Approval of Additional Indication for Vyxeos (daunorubicin and cytarabine) for the Treatment of Secondary Acute Myeloid Leukemia in Pediatric Patients
DUBLIN, March 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) approved a...
Akebia Submits New Drug Application (NDA) to the FDA for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis
CAMBRIDGE, Mass., March 30, 2021 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives...
U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New...
Mirum Pharmaceuticals Announces FDA Acceptance of New Drug Application and Priority Review for Maralixibat in Alagille Syndrome
FOSTER CITY, Calif.--(BUSINESS WIRE)--Mar. 29, 2021-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) announced today that its New Drug Application (NDA) for...
TG Therapeutics Completes Rolling Submission of Biologics License Application to the U.S. Food and Drug Administration for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia
NEW YORK, March 29, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced the completion of the rolling submission of a Biologics...
NIH Begins Study of Allergic Reactions to Moderna, Pfizer-BioNTech COVID-19 Vaccines
April 7, 2021 -- A clinical trial is underway to determine whether people who are highly allergic or have a mast cell disorder are at increased risk for an...
Moderna Highlights Publication of Antibody Persistence Data of its COVID-19 Vaccine out to 6 Months in the New England Journal of Medicine
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Apr. 7, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and...
Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing
New Brunswick, NJ (April 3, 2021) – Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19...
Pfizer and BioNTech Confirm High Efficacy and No Serious Safety Concerns Through Up to Six Months Following Second Dose in Updated Topline Analysis of Landmark COVID-19 Vaccine Study
Thursday, April 01, 2021 Analysis of 927 confirmed symptomatic cases of COVID-19 demonstrates BNT162b2 is highly effective with 91.3% vaccine efficacy...
Pfizer-BioNTech Announce Positive Topline Results of Pivotal COVID-19 Vaccine Study in Adolescents
March 31, 2021 In participants aged 12-15 years old, BNT162b2 demonstrated 100% efficacy and robust antibody responses, exceeding those reported in trial of...
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